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From: Smith, Michael (CBER)
Sent: Wednesday, April 20, 2022 10:45 AM
To:Collins, Kathleen Mary Catherin e
Cc:Naik, Ramachandra <[email protected]>; Gottschalk, Laura
<[email protected]>; Mineo, Gosia ; Harkins Tull, Elisa
<[email protected]>; Devlin , Carmel M <[email protected]>
Subject: STN 125742/45: IR RE PVP
Kate,
The review team has the below information request regarding the Pharmacovigilance
Plan (PVP) that was submitted to STN 125742.45.
In reference to sBLA 125742/45, please revise your Pharmacovigilance Plan (PVP)
(Version 1.4, dated December 15, 2021) to include both Tris/Sucrose and PBS/Sucrose formulations. Please submit the combined PVP in an amendment to the efficacy supplement by May 4, 2022, and include a track changes and clean running version.
Regards,
Mike
- Please confirm receipt of this email and let us know if you have any questions.
Mike Smith, Ph.D.
Captain, USPHS
Senior Regulatory Review Officer
Food and Drug AdministrationCenter for Biologics Evaluation & ResearchOffice of Vaccines Research & ReviewDivision of Vaccines and Related Products Applications
Tel: 301-796-2640
[email protected]
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Michael J.
Smith -S4Digitally signed by Michael J. Smith -S4 Date: 2022.04.20 10:48:21 -04'00'
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FDA-CBER-2022-5812-0500365
FDA-CBER-2022-5812-0500366